OPUS® 2.5 - 80R Pre-packed Columns
LEADER OF THE PACK
OPUS® Pre-packed Chromatography Columns provide linear scale-up from process validation to commercial and GMP manufacturing.
Repligen is revolutionizing how modern chromatography is performed. The result? Unprecedented recovery and operational efficiencies even with the most complex modalities.
Click on the image highlights to see key elements of chromatography redesigned.
Largest scale, broadest range
In response to the need to scale up chromatography processes, Repligen offers the largest pre-packed columns for the bioprocess industry. OPUS® 45R, 60R and 80R Columns are the first pre-packed columns designed to meet the chromatography requirements of larger 1000L and 2000L single-use bioreactors.
- Easily configured for bed height, resin, and application
- Seamless scale-up from smaller OPUS® Columns
- Complete documentation package for GMP use
- Significant time and cost savings compared to conventional column technology
- Consistent materials of construction
- Class VI, EMA 410/01 compliant materials
- GMP and pre-GMP quality packages
- ISO documentation (CoA, RSF)
- Select from > 150 resins
- Individual column release testing
Packed with user-specified resins
Repligen packs > 250 resins from 60 resin families >15 resin vendors. The most frequently packed resins are 30-120μm in particle size and based on matrices of agarose, methacrylate, cellulose, and polystyrene material. Resins may be customer-supplied or Repligen-supplied. A convenient resin pick-up service is available upon approval.
Repligen CaptivA® and CaptivA® HF
IEX/Mixed Mode Resin
JSR Amsphere™ A3
ABT Rapid Run Agarose Bead (IEX)
Access CHT™ Resin pre-packed in OPUS Columns
Ceramic hydroxyapatite (CHT™) resin offers unique selectivity during the purification of mAbs and recombinant proteins. OPUS Columns can now be pre-packed with CHT™ resin and shipped world wide with excellent performance.
- Internal diameters from 5 - 45 cm
- Bed heights from 5 - 30 cm
View the full performance data
CHT™ is a trademark of Bio-Rad Laboratories, Inc.
Performance maintained after shipping
Average plate count and asymmetry variance post-shipping was within 8% and 3%, respectively, of the pre-shipping value. Absolute values were within the specification window.
Innovative resin recovery port
From pre-packed to unpacked
With an innovative side port that allows for easy resin unpacking, OPUS 45R, 60R, and 80R Columns provide the ultimate flexibility in pre-packed column technology.
Without compromising chromatographic performance or cleanability, the new feature helps mitigate the risk of implementing pre-packed columns in GMP settings, and allows for re-use of the unpacked resin in other columns.
In the event of a deviation, and if the OPUS pre-packed column performance cannot be recovered, the column can be unpacked and the resin can be repacked into a traditional, self-packed column.
After the intended usage of the OPUS pre-packed column, the column can be unpacked and resin transferred to a development or pilot setting for additional use.
OPUS® flow distributors are designed to maintain uniform flow distribution. The design leverages industry-accepted technology, including a radial flow field and anti-jet funnel.
During the development of OPUS® columns, dispersion as a function of column performance was modeled to confirm critical parameters of the flow distributor. The final design was qualified through computational fluid dynamics modeling and applications case studies performed in the OPUS® applications lab.
Constructed from a medical grade polypropylene homopolymer, all product contact surfaces in OPUS® Columns are EMA 410/01 (or Animal Free) and Class VI Compliant.
|Component||Material of construction|
|2.5 - 30 column tube||Polypropylene|
|45R - 80R column tube||70% w/w E-Glass / PP engineered composite structure|
|Inlet and outlet||Polypropylene|
|Bed support screens||Polypropylene|
|O-rings||Platinum-cured medical grade Silicone|
|Return line||Platinum-cured medical grade Silicone with a strong polyester fiber reinforcement|
OPUS® Columns are compatible with accepted cleaning and sanitization protocols used in typical downstream processing campaigns for monoclonal antibodies, recombinant proteins, or vaccines.
Using colorimetric measurement of phosphate reduction, an OPUS® 20 Column packed with 6 FF was reliably cleaned of residual phosphate in just 2 CVs.
- OPUS® Columns contain no significant dead spaces
- OPUS® Column design is easily cleanable
Impact on process economics
Substantial savings in manufacturing costs and labor are realized because OPUS Columns offer the benefits that come with pre-packed technology:
- No up-front capital expense
- Reduction of CIP procedures and cross contamination
- Faster campaign turnaround time
- Operational excellence (reduced labor requirements)
In this example, over 65% cost savings and up to 80% labor savings were achieved when using OPUS Columns compared to self-packed columns.*
*Assumptions: OPUS 60R Pre-packed Column versus purchase of new 60 cm diameter automated self-pack equipment (columns are dedicated to a specific molecule). Data presented are estimates and subject to change.
OPUS® 2.5 - 80R Pre-packed GMP-ready Columns
OPUS® Pre-packed Chromatography Columns provide linear scale-up from process validation to commercial and GMP manufacturing. Select from the broadest portfolio of pre-packed GMP-ready column sizes, including large scale OPUS® 45R, 60R, and 80R Columns. Pre-packed columns enhance facility efficiency overall by converting column packing resources into productive chromatography and accelerating campaign turnaround time.
Innovation in Purification
- Configure bed height to nearest mm
- Pack nearly any resin from nearly any supplier
- Customize plat count, asymmetry and test method
- Unpack resin using recovery port featured on OPUS® 45R, 60R and 80R columns
- Packed in ISO Class 7 clean rooms
- Complete Regulatory Support File
- Certificate of Analysis for each column configuration
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OPUS® Columns pack your choice of resin and the most precious element of all, time, into a self-packed ready-to-use chromatography column at almost any size and for almost every application. Skip months of hardware validation, execute more runs--and still leave work early to enjoy a bike ride. Don’t worry, we won’t tell your boss.
Reallocate column packing time and resources toward productive GMP-level chromatography, even at small-scale. The family of OPUS® Pre-packed Columns now includes the small but mighty OPUS® 2.5. Scale GMP purification effortlessly from 2.5 cm to 80 cm ID.
Manufacturing Centers of Excellence
Repligen develops and manufactures products for the biopharmaceutical industry under an ISO 9001 quality management system. We focus on the timely delivery of high quality, consistent and robust products, to ensure business continuity for our customers.
Repligen manufacturing sites are located in Massachusetts, California, and New Jersey in the United States and in Sweden, France, The Netherlands, Germany and Estonia.
Support is part of the Repligen DNA. Our goal is to provide exceptional customer experience, and to support the efficient and successful adoption and implementation of all Repligen products and services.
- Field Application Support
- Customer Service
- Field Service Engineers